FDA UDI
In Commercial Distribution
🇺🇸 United States
SURFIX Alpha
DI: 10381780048589
·
Model: 195300SND
·
NEWDEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SURFIX Alpha
- Primary DI
- 10381780048589
- Version / Model
- 195300SND
- Catalog Number
- 195300SND
- Company Name
- NEWDEAL
- Labeler DUNS
- 536935331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-09
- Public Version
- 6
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 404d785b-2c22-427a-80d2-2d61b2d295f1
- Distribution End Date
- 2027-12-31
Device Description
Titanium alloy sterile variable angle washer belonging to the Newdeal angular locking system fixation. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61671 | Orthopaedic bone washer, sterile | A sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780048589 | GS1 | ||||
| Secondary | M248195300SND1 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073375 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3.5mm diam. |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place.